The FDA probe follows an alert by Valisure, a Connecticut-based online pharmacy that tests all the medications it dispenses, stating that it had detected high levels of NDMA in both generic and brand name versions of Zantac, which are sold at major retailers across the U.S. including Walgreens, CVS, and Walmart.
Ranitidine is an antacid and antihistamine medicine used to treat and prevent a range of gastrointestinal disorders including Zollinger-Ellison syndrome and gastroesophageal reflux disease (GERD). The drug was introduced into the U.S. market in 1981, and by 1987 had become the world’s best-selling prescription medication.
Zantac is manufactured and marketed by Sanofi, a multinational pharmaceutical company headquartered in Paris, France. Sanofi manufactures Zantac in Mexico and sources ranitidine from pharmaceutical companies in Spain, according to Bloomberg.
N-nitrosodimethylamine is used in gasoline, as a stabilizer for industry materials, and as a lubricant additive, according to the EPA. The chemical is also used to make liquid rocket fuel, and is a byproduct of manufacturing certain pesticides and processing fish.
Valisure has called on the FDA to issue a nationwide recall for ranitidine over “excessive” levels of NDMA; the agency maintains levels of the impurity in ranitidine medicines are low and not likely to present a significant health threat.
Though the FDA stopped short of recalling Zantac, it did recommend that patients who take the drug talk to their doctor about NDMA contamination, their risk of cancer, and alternative medicines with fewer potential side effects.